Novartis and the University of Oxford’s Big Data Institute have announced that they are to establish a five-year research alliance using artificial intelligence to understand complex diseases and improve drug development.

The alliance plans to analyse huge data sets using artificial intelligence and machine learning to spot disease insights that have been undetectable to scientists thus far, expecting to transform how ultra large and multiple datasets are analysed, combined and interpreted to identify early predictors of patient responses to treatments for inflammatory diseases, such as multiple sclerosis (MS) and psoriasis.

The alliance will draw on data from around 5 million patients from the UK and international partner organisations, together with anonymised data captured from relevant Novartis clinical trials.

Using the BDI’s latest statistical machine learning technology and experience in data analysis, combined with Novartis’ wealth of clinical expertise and clinical trial data, the alliance expects to predict how patients will respond to existing and new medicines.

“Our collaboration with Novartis will enable both organisations to transform the scale and efficiency of clinical research at an unprecedented rate though the sharing of data, technology, and advanced analytics expertise” said Professor Gil McVean, director of the Big Data Institute.

“The BDI enables people and projects to span traditional boundaries and scientific disciplines, and leverage technological innovation for the benefit of patients.”

There are so many theories on how to improve clinical trial recruitment. There are endless panels, discussions, conferences, webinars, press releases, white papers, and interviews on how to improve clinical trial recruitment and success. The majority of these recommendations miss the mark completely. Is your 2019 goal to improve clinical trial recruitment?Here’s what you need to do from a patient and carepartner’s perspective to fundamentally improve clinical trial recruitment and your trial’s lifecycle and success:

Include patients and carepartners in the ideation and design of the clinical trial lifecycle.

This is a must, not a nice to have. This is solid business strategy, not a marketing tactic or buzzword. You can’t afford to not get a trial right the first time or not fill your trial. Until you have patients and carepartners partnering with your company throughout the clinical trial lifecycle, interacting with every department of your company, you have haven’t overturned every stone. While you’re at it, stop using the words “patient-centered”.

Speak to every single patient who completes their trial and ask for their insights and expertise immediately. Even better, ask for their insights and expertise throughout the trial. Don’t just speak to people who have participated and successfully completed clinical trials. Welcome those who didn’t qualify due to exclusion criteria. Seek the voices of those who faced too many social determinants of health barriers that made participation unfeasible. Invite those who mistrust the clinical trial process. Listen to the carepartners who did everything in their power to support their loved ones’ participation in a trial and yet they still dropped out, suffered immensely, or died. Invite the young adults who are the primary carepartners for their loved ones due to language barriers and cultural circumstances.

These are the real-world experiences and lives you need to intersect with. It’s going to be uncomfortable. Embrace it. It will be worth it and will change and inspire you. Pro-tip for the record: AI is not going to help you with this.

3. Stop looking for volunteers to simply fill your quotas. You need to start looking for research partners.

Clinical trials are a commitment and a profound sacrifice. Many patients strongly express that they want to be proactive in advancing science and medicine. Welcome people to sign up for trials as your research partners.

By shifting the lens from volunteer to research partner, the entire perspective as to meaning of the relationship, the sanctity of the commitment, and the importance of the work takes an entirely different perspective from both sides. Forge a trusted, longitudinal research partnership and many downstream challenges, such as adherence and retention, can be managed proactively vs in a back-peddling manner, or worse, an incomplete trial that can’t fulfill statistical significance (AKA millions upon millions of dollars lost and potential life-saving treatments never coming to market).

4. Budget to cover ALL expenses of participating in a trial.

Financial toxicity is a significant barrier to access. Participating in clinical trials does not come without expenses. Many physicians, let alone patients, are shocked to find out that certain tests and requirements of the trial are the patient’s responsibility. There must also be considerations for travel, time lost from work, childcare, elder care, hospital visits and admissions due to treatment side effects, hotels accommodations or even temporary housing. Make addressing financial toxicity a priority.

The money is there, it’s the priorities that need alignment with what brings value to patients. Still struggling to come up with funding to cover these expenses? Find ways to leverage technology to bring trials to patients. Or there’s always those massive marketing budgets that you could dip into.

5. Invite patients and carepartners to visit your company. Have them speak with members of your compliance, regulatory, finance, marketing, leadership, and scientific research teams regularly.

When’s the last time any of these teams spoke with a patient or carepartner? Internal teams need to hear first-hand the stories of success and failure and understand all the barriers to participation. Patient advocacy and engagement teams may already be regularly working with patients. It needs to be bigger, company-wide. You’re either all in or you’re not.

Clinical trial success depends on the entire company. Pharma’s internal culture needs a landslide change. Listening to patient and carepartner stories is inspirational for the people who are graced to hear their words. Welcoming patients and their loved ones to your company is an exceptional opportunity to build empathy, bring joy, connection, and instill a sense of purpose to your work environment. Patients and carepartners often state that being welcomed to tell their story and share their experiences and expertise to be healing and empowering.

This is a win-win and more powerful than any commercial or marketing tactic you have in your projected pipeline.

6. Leverage social media to bring your clinical trials to the forefront.

Use social media platforms as ways to educate the general public about clinical trials, dispel myths, amplify the benefits of participating in clinical trials. Be the pioneers in sending the message that your company isn’t just looking for volunteers, you are looking for research partners to advance science and medicine. Be strategic and savvy about hashtags! Peer-to-peer patient and carepartner support groups, patient leaders, and advocates spread credible content and messages about cutting-edge research throughout their communities at lighting speed and virally.

Pharma must conquer its fear of social media. Meet patients where they are.

7. Provide digital tools for clinical trial exploration and matching to be offered at point of care (POC) for patients and doctors to use.

Many physicians state they do not have an easy way to search for clinical trials that may be of interest for a particular patient. If they can’t look it up quickly while talking to a patient, they sure as heck aren’t going to discuss it as a treatment option. Remove the barriers by leveraging technology NOW!

Patients and their loved ones often spend hours in waiting rooms and exam rooms with nothing to do. Having access to a digital tool and a simple chatbot for clinical trial exploration and matching based on diagnoses, genetic mutations, basic demographics, and geographic locations would connect patients with the opportunities currently available.

This needs to become a mainstream part of preparing patients for their appointments, especially for those diagnosed with chronic illnesses and cancer.

8. Dispel myths associated with trials at a health literacy people can understand.

Emphasize the high caliber of care & support people receive during a trial. Highlight positive patient and carepartner stories in a culturally sensitive manner. There’s a great deal of good that is being done on the frontlines to improve the clinical trial process! There are success stories and strides being made.

There are so many good people who work in pharma and are dedicated to literally saving people’s lives. We need to do a better job of communicating that dedication and passion to the general public, to patients, carepartners, our colleagues in medicine, and within the walls of your companies.

9. Work to update treatment guidelines to encourage discussion of clinical trials as a treatment option earlier in treatment planning. Clinical trials should not be a last resort.

When all treatment options have failed, many patients are devastated to learn that they do not qualify for trials because they have been treated with too many other therapies or are too sick. Have you ever heard a patient say they wish they knew about clinical trials earlier because now it’s too late? Hearing that literally knocks the wind out of you and is soul-crushing.

No patient should ever feel like they missed their opportunity. Patients have a right to be informed about all treatment options, including clinical trials. Physicians must have the tools they need to seamlessly include discussions on clinical trials at POC and patients and carepartners need to be able to proactively explore trials. They won’t and can’t participate in something they don’t know about.

10. Try signing up for your own trial.

Go through every step of the process. Bonus points if you can get through a search on clinicaltrials.gov and get in touch with a human being using the contact number listed. Travel to the clinical trial site. Acquire your medical records in preparation for your intake appointment. Book a flight, hotel, find public transportation or take an Uber or Lyft to the enrollment site. Try finding the building, suite, and office. Review the consent forms.

Would you agree to 5 spinal taps, endless bloodwork, poorly coordinated care, no access to your medical records, out-of-pocket responsibilities for imaging, and no access to digital technologies or telemedicine? Does this sound exhausting, frustrating, or leave you outraged? You have some homework to do. Go back to step 1.

In 2018, FDA approved an all-time record of 62 new therapeutic drugs (NTDs) [Not including diagnostic imaging agents, included are combination products with at least one new molecular entity as an active ingredient] with average Peak Sales per NTD $1.2Billion.

For those of us that use the Gregorian calendar, this time of year is one for reflection. We look back at the year just gone and forward to the year to come and, armed with a list of best-self resolutions, we step into January full of hope and intention. Like most years, 2018 was a busy one for the pharmaceutical industry – best characterized perhaps not as a year of radical change but as 12 months of under-the-surface action. (But if you disagree, please do let me know).

A variety of emerging technologies from smart speakers to virtual/augmented reality to wearable devices are expected to change the way healthcare services are delivered. According to Kantar Media’s 2018 Digital Insights Study, 1 out of 4 doctors surveyed indicate they already use one or more of the healthcare technologies measured.

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